Memorandum Summary
• Based on increasing concerns about the absence of informed patient consent prior to allowing practitioners or supervised medical, advanced practice provider, or other applicable students to perform training- and education-related examinations outside the medically necessary procedure (such as breast, pelvic, prostate, and rectal examinations), particularly on anesthetized patients, we are reinforcing hospitals’ informed consent obligations.
• Requirements related to informed consent for hospitals are found throughout the Hospital Conditions of Participation (CoPs): the Patient’s Rights CoP at 42 CFR 482.13(b)(2); the Medical Record Services CoP at 482.24(c)(4)(v); and the Surgical Services CoP at 482.51(b)(2).
• Surveyors must ensure that a hospital’s patient informed consent policy and process, as well as its informed consent forms, contain elements and information that allow for a patient, or his or her representative, to make fully informed decisions about their care.
• CMS is revising its hospital interpretive guidance about informed consent in the State Operations Manual, Appendix A-Hospitals, to address this.
Sign up to get the latest information about your choice of CMS topics. You can decide how often to receive updates.
A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services.
7500 Security Boulevard, Baltimore, MD 21244